Methods, systems, and apparatus for performing minimally invasive coronary artery bypass graft surgery

ABSTRACT

A system for performing vascular surgery includes a first retractor blade and a second retractor blade and a fulcrum device. The first retractor blade includes a first grasping bar, and the second retractor blade comprises a second grasping bar. The first retractor blade and the second retractor blade are adapted to engage opposing edges of a subcostal incision in a patient. The fulcrum device includes a first fulcrum slot and a second fulcrum slot formed through opposing edges of the fulcrum device. The first fulcrum slot is adapted to receive the first grasping bar and the second fulcrum slot is adapted to receive the second grasping bar, such that the fulcrum device is adapted to apply leverage from the first retractor blade and the second retractor blade to spread the edges of the incision and to allow access to a chest cavity of the patient.

[0001] This application claims the benefit of U.S. Provisional PatentApplication No. 60/427,248, filed Nov. 19, 2002, which is incorporatedherein by reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] This invention relates to the field of less or minimally invasivesurgery for the purposes of revascularizing tissue. In particular, theinvention relates to methods, systems, and apparatus for performing lessor minimally invasive, Coronary Artery Bypass Grafting (CABG) surgeryfor the purposes of revascularizing tissue. Still more particularly,such systems and methods may employ conduit coupling devices.Specifically, conduit coupling devices may be used which are formed fromcouplers to connect conduits, such as arteries, veins, or the like, andto establish fluid communication therebetween and methods forestablishing such fluid communication using such coupling devices.

[0004] 2. Description of Related Art

[0005] Arteries supply tissue with nutrients and oxygen carried byblood. When arteries become diseased or obstructed, the delivery ofblood to tissue may be compromised. When the tissue is denied suchnutrients and oxygen, the tissue becomes ischemic and necrotic. Healthyarteries and veins may be harvested from other parts of the body andconnected to diseased or obstructed vessels to bypass the diseased orobstructed portions and to restore delivery of blood to tissue, therebyreducing or preventing further tissue damage or loss. Once completed,the bypass may deliver blood flow to tissue distal to the obstruction,thereby reducing or preventing further tissue loss. When such proceduresare performed on the heart, such procedures have been called CABGsurgery.

[0006] Known CABG surgery methods have been performed for years bystopping the heart, placing the patient on Cardiopulmonary Bypass (CPB)apparatus, and opening the chest cavity by cutting through the ribs atthe sternum. Bypass vessels then may be attached to the diseasedarteries by tedious and time-consuming suturing techniques. Although thesurgeon may gain the least obstructed access to the patient's heartthrough the ribs, i.e., by “cracking” the patient's chest, the patient'srecovery may be delayed and the risk of infection and othercomplications associated with heart surgery may increase with suchinvasive techniques. Bypass suturing of this type is performed using asurgical procedure in which the chest wall remains open, therebyexposing the heart. Because such bypass procedures may betime-consuming, a patient may be subjected to prolonged anesthesia andto the use of a CPB or other cardiopulmonary support system. Prolongedexposure of a patient to these conditions may increase the likelihood ofadverse reactions including delayed recover or loss of mental faculty,stroke, or death.

[0007] As noted above, known surgical bypass techniques may involve theharvesting of a blood vessel from the chest wall or the leg of a patientfor use as a bypass conduit. The bypass procedure involves extensivepreparation of the bypass vessels; careful positioning of the bypassvessels at the bypass site; and meticulous suturing. The reduced size ofsutures used may require the surgeon to use of optical magnification.Such bypass procedures are technically challenging with results highlydependent upon the skill of the surgeon. If the attachment point betweenthe bypass vessel and the obstructed or diseased vessel is not alignedproperly, a disturbance of the blood flow may occur, resulting in areduction in the size of the opening between the vessels. Eventually, insuch cases, the bypass opening may close, thereby further obstructing aflow of blood to tissue.

[0008] One way to reduce the time during which a patient is subjected toanesthesia and CPB or other support systems has been to develop lessinvasive approaches to cardiac surgery. Recently, attempts have beenmade to develop less invasive surgical techniques, but these techniqueshave met with only limited success. While the use of less invasiveprocedures employing access devices called “ports” has been attempted,thus far, this approach has achieved limited acceptance due todifficulties that may arise when suturing bypass vessels from a remotelocation through such ports.

SUMMARY OF THE INVENTION

[0009] A need has arisen for improved surgical methods, systems, andapparatus for performing less or minimally invasive surgeries and, inparticular, less or minimally invasive CABG surgeries. It is a technicaladvantage of such surgical methods, systems, and apparatus that thesurgeon may make a smaller incision in the patient's chest and that itis not necessary to cut through the patient's ribs. It is a furthertechnical advantage that of such surgical methods, systems, andapparatus that they may employ or comprise a fulcrum device to hold theincision open during the surgery or a holder for surgical instruments,which may free a surgeon's hand during surgery, or both. It is still afurther technical advantage that of such surgical methods, systems, andapparatus that they may employ or comprise a cannula, which combines thefunctions of a heart manipulation device and a catheter, to providecardiopulmonary bypass and to deliver cardioplegia solution within theconfines of the substantially closed chest cavity.

[0010] A need also has arisen for a conduit coupling device that may beintroduced and positioned through a port in a patient's body, therebyeliminating the need for more invasive surgical procedures that involveopening the chest wall and thereby reducing operative time during whicha patient may be subjected to anesthesia and cardiopulmonary support. Afurther need has arisen for a conduit coupling device that may beattached without the need for fine suturing techniques by a surgeon. Astill further need has arisen for a conduit coupling device comprising apair of couplers that may be positioned in adjacent or nearby conduitsto bypass obstructed or diseased portions.

[0011] It is an advantage of such methods, systems, and apparatus thatthe surgeon need not open the chest cavity to gain access to the heartthrough the ribs, thereby reducing or minimizing trauma to the patientand speeding recovery. It is a further advantage of such methods,systems, and apparatus that the surgeon may place the patient on CPB orother cardiopulmonary support systems in order to allow manipulations ofthe heart that are needed to access the coronary arteries on the leftside of the heart, and also to decompress the heart to provide room inthe chest for instrument access. It is still a further advantage of suchmethods, systems, and apparatus that the vessels used to bypass diseasedvessels may be reattached to the diseased vessels with uniqueanastomosis conduit coupling devices that eliminate the need forsuturing.

[0012] A conduit coupling device according to this invention permits theattachment of blood vessels, such as arteries or veins, to obstructed ordiseased arteries to bypass the obstructed or diseased portion. Oneadvantage of the device is the ease and speed of attachment of couplersto conduits, eliminating a need for fine suturing techniques. Theconduit coupling device of the present invention also improves theconsistency and quality of the anastomotic procedure, which is lessdependent upon surgical technique than known bypass suturing techniques.By eliminating suturing, this device and method may be performed usingports and similar surgical techniques that are less invasive. Thus,consistency of the conduit opening and flow path are less dependent uponthe suturing ability of a surgeon. Use of the devices and methodsdisclosed herein may reduce operation time and risks associated withCABG surgery compared to known bypass devices and methods. Each couplerof a conduit coupling device according to the present invention providesa smooth, hemodynamic opening and establishes a fluid flow path betweenconduits being connected by the conduit coupling device.

[0013] According to an embodiment of the invention, a coupler comprisesa saddle, a channel, a tissue clamp, and a flange. The channel has afirst end having a substantially elliptical cross-section connected tothe saddle and a second end having a substantially circularcross-section. The tissue clamp is positioned around the channel. Theflange is formed adjacent to the second end of the channel. A conduitcoupling device may be formed by securing flanges of two couplerstogether.

[0014] According to another embodiment of the invention, a method ofconnecting two conduits comprises the following steps. A first saddle ofa first coupler is positioned within a first conduit. A second saddle ofa second coupler is positioned within a second conduit. The firstconduit is clamped to the first saddle of the first coupler. The secondconduit is clamped to the second saddle of the second coupler. The firstcoupler and the second coupler are connected.

[0015] According to a further embodiment of the invention, a conduitcoupling device comprises a first coupler, a second coupler, and aclamping ring. The first coupler comprises a first saddle, a firstchannel, a first tissue clamp, and a first flange. The second couplercomprises a second saddle, a second channel, a second tissue clamp, anda second flange. The clamping ring secures the first flange and thesecond flange together. The first and second couplers may be joinedtogether at different angles relative to one another, depending upon theorientation of the conduits to be connected by the conduit couplingdevice.

[0016] According to still a further embodiment, the invention is acoupler holder and delivery device for holding and delivering a couplerto a blood vessel. The coupler comprises a saddle; a channel, whereinthe channel comprises a first end connected to the saddle and a secondend, a tissue clamp positioned around the channel; and a flange formedadjacent to the second end of the channel. The coupler holder anddelivery device comprises an outer tube surrounding an inner shaft, suchthat the outer tube is slidable on the inner shaft and independently ofthe inner shaft; a coupler conforming end, which is mounted on a firstend of the inner shaft and is adapted to engage the second end of thechannel of the coupler; and a pair of opposing, tissue clamp receivingflanges mounted on opposite sides of a first end of the outer tube andadapted to engage the tissue clamp bend the tissue clamp away from thesaddle. The outer tube is slidable toward the first end of the innershaft to engage the flanges to the tissue clamp. Conversely, the outertube is slidable away from the first end of the inner shaft to releasethe tissue clamp from the flanges.

[0017] According to yet a further embodiment, the invention is a methodfor delivering a coupler into a blood vessel. The coupler comprises asaddle; a channel, wherein the channel comprises a first end connectedto the saddle and a second end; a tissue clamp positioned around thechannel; and a flange formed adjacent to the second end of the channel.The method comprising the steps of engaging the channel of the coupler;engaging the tissue clamp and bending the tissue clamp away from thesaddle; making an incision into the blood vessel; delivering the couplerinto the blood vessel through the incision; securing the saddle to theblood vessel; and releasing the tissue clamp, so that the tissue clampconforms to the saddle.

[0018] In another embodiment, the invention is a system for performingvascular surgery. The system comprises a first retractor blade and asecond retractor blade, wherein the first retractor blade comprises afirst grasping bar and the second retractor blade comprises a secondgrasping bar and wherein the first retractor blade and the secondretractor blade are adapted to engage opposing edges of an incision,e.g., a subcostal incision, in a patient. The system further comprises afulcrum device. The fulcrum device comprises a first fulcrum slot and asecond fulcrum slot formed through opposing edges of the fulcrum device,wherein the first fulcrum slot is adapted to receive the first graspingbar and the second fulcrum slot is adapted to receive the secondgrasping bar, such that the fulcrum device is adapted to apply leveragefrom the first retractor blade and the second retractor blade to spreadthe edges of the incision and to allow access to a chest cavity of thepatient.

[0019] The system further may comprise a first bar and a first mountingbracket and a second bar and a second mounting bracket. The firstretractor blade is mounted adjustably, e.g., slidably, and pivotably onthe first bar by the first mounting bracket and the second retractorblade is mounted adjustably, e.g., slidably, and pivotably on the secondbar by the second mounting bracket. In this manner, a separation betweenthe first retractor blade and the second retractor blade is adjustableto increase or decrease the separation between the edges of the incisionin the patient.

[0020] The system further may comprise a surgical table comprising acentral support for supporting the patient's head and trunk, a pair ofarm supports extending from opposing edges of the central support, and apair of leg supports for supporting and separating the patient's legs.In this manner, an angle of separation between the patient's legs isadjustable to permit improved access to the patient's chest by a surgeonstanding between the patient's legs.

[0021] The system further may comprise a first bar and a first mountingbracket and a second bar and a second mounting bracket. The firstretractor blade is mounted adjustably, eg., slidably, and pivotably onthe first bar by the first mounting bracket and the second retractorblade is mounted adjustably, eg., slidably, and pivotably on the secondbar by the second mounting bracket. The first bar and the second baralso may be mounted on the surgical table. In this manner, a separationbetween the first retractor blade and the second retractor blade isadjustable.

[0022] The fulcrum device of this system may comprise a perimeter liphaving an access opening, e.g., a window-like opening, formedtherewithin, a pair of parallel first rails which extend across theaccess opening, and an instrument support slidably mounted between thepair of parallel first rails, such that the instrument support holds asurgical instrument inserted into the patient's chest cavity. Theinstrument support further may comprise a pair of first graspingrunners, which slidably engage the pair of parallel first rails; a pairof parallel second rails which extend between the pair of first graspingrunners; and an instrument port slidably mounted between the pair ofparallel second rails. In this manner, the instrument port ispositionable within the access opening along a first axis parallel tothe pair of parallel first rails and along a second axis parallel to thepair of parallel second rails and perpendicular to the first axis. Theinstrument port further may comprise a pair of second grasping runners,which slidably engage the pair of parallel second rails, and aninstrument access orifice formed therethrough. The instrument accessorifice may receives a surgical instrument and hold it at a positionwithin the access opening. Other instruments may be manipulated directlythrough the access opening. The fulcrum device also may comprise a lightsource to illuminate the chest cavity. The light source may comprise aplurality of light emitting diodes (LEDs) arrayed about a side of theperimeter lip facing the patient's chest cavity. In yet anotherembodiment, the light source may comprise at least one fiber optic cableto convey light to a plurality of fiber optic cable ends arrayed about aside of the perimeter lip facing the patient's chest cavity.

[0023] A variety of instruments may be used in this system andmanipulated through the fulcrum devices access opening. An endoscope andan endoscope holding device, wherein the endoscope holding device maycomprise a first ball joint, a second ball joint, and a manipulatingshaft extending between the first ball joint and the second ball joint;an endoscope stabilizing device supporting the second ball joint,whereby the endoscope holding device is fixed to a stationary object; ahandle mounted on the first ball joint comprising a passage formedtherethrough for receiving the endoscope and a activating lever. Thefirst ball joint and the second ball joint are thereby released andsecured.

[0024] A dissecting instrument for separating tissue may comprise ahandle, a shaft, and a tip, wherein the shaft is rotatable and the tipis rotatable and pivotable on the shaft. The tip further may comprisedissecting means. The dissecting means may comprises a spatula endaffixed to a spatula end shaft and a grasper jaw affixed to the spatulaend shaft, such that the grasper jaw is brought into contact with thespatula end to blunt dissect tissue positioned therebetween. A firstbutton mounted on the handle may be manipulated to pivot the tip viamechanical couplings within the shaft, and a second button mounted onthe handle may be manipulated to actuate the grasper jaw via mechanicalcouplings within the shaft. In another embodiment, the dissecting meanscomprises a source of CO₂ and a gas flow passage for conveying CO₂ tothe tip. In this manner, a flow of CO₂ separates impacted tissue intonatural tissue planes prior to dissection. In still another embodiment,the dissecting means may comprise a source of RF energy and a conduitfor conveying RF energy to an innermost surface of spatula end shaft. Inthis embodiment, the second button mounted on the handle is manipulatedto actuate the grasper jaw via mechanical couplings within the shaft toseize tissue to coagulate blood in the tissue prior to dissection.Alternatively, the dissecting means may include a combination of some orall of these embodiments.

[0025] A cannula for use in this system may comprise a stabilizer andmanipulation component and a catheter component. The stabilizer andmanipulation component may be adapted to receive the catheter componentand may comprise a suction cup adapted to secure the stabilizer andmanipulation component to an apex of the patient's heart; a suction tubethrough which fluid is drawn to create suction between the suction cupand the heart; a stabilizer shaft which passes through the suction cupand is adapted to penetrate the heart through an incision; a hemostaticvalve in communication with the stabilizer shaft for insertion of thecatheter component into the heart; and a manipulator arm and handle forguiding the suction cup into contact with the heart. The cathetercomponent may be adapted to be received by the stabilizer andmanipulation component and may comprise at least one catheter tubeadapted to pass through the stabilizer and manipulation component in tothe patient's heart; a proximal balloon, which deploys radially in theleft ventricle; a distal balloon that deploys radially in the ascendingaorta, at least one radial discharge opening formed in the at least onecatheter tube between the distal balloon and the proximal balloon; and adistal discharge opening formed at the tip of the at least one cathetertube.

[0026] Tissue scissors may comprise a scissors handle, a scissors shaft,a distal end pivotable on the scissors shaft at a distal end joint; aslidable button mounted on the scissors handle and operably connected tothe distal end joint, whereby the distal end is pivoted; a pair ofscissor blades mounted on the distal end; and a handle ring operablyconnected to at least one of the pair of scissor blades, whereby atleast one of the pair of scissor blades in urged into contact with theother of the pair of scissor blades. Such tissue scissors further maycomprise a source of RF energy and a conduit for conveying RF energy toat least one of the pair of scissor blades.

[0027] Yet another instrument for use in this system, is a couplerconnection device for connecting a pair of couplers to each other. Sucha coupler connection device may comprise a connection shaft, a pair ofcoupler connecting arms, and a connecting pivot; wherein each of thecoupler connecting arms further comprises a pair of arched fingerspositioned at the end of the coupler connecting arm opposite theconnecting pivot, which grasp one of the pair of couplers, and whereinat least one of the pair of coupler connecting arms pivots on theconnecting pivot towards the other of the pair of coupler connectingarms to connect the couplers to each other.

[0028] In still yet a further embodiment, this invention is a method ofperforming vascular surgery. This method may comprise the steps of:making a subcostal incision in a patient; engaging opposing edges of theincision with a first retractor blade and a second retractor blade;mounting a fulcrum device on the first retractor blade and the secondretractor blade; retracting the incision to provide access to thepatient's chest cavity through which to operate; placing a heart bladethrough the fulcrum device; inserting an endoscope through the fulcrumdevice to locate damage in a coronary vessel; positioning the heart withthe heart blade to expose the damaged coronary vessel and a branch ofthe Internal Mammary Artery (IMA); inserting a cannula through thefulcrum device into the apex of the patient's heart to place the patienton cardiopulmonary bypass; making a vessel incision in the coronaryvessel downstream from the located damage in the coronary vessel andinserting a first conduit coupler into the vessel incision; making anIMA incision in the IMA and inserting a second conduit coupler into theIMA incision; connecting the first conduit coupler to the second conduitcoupler; removing the cannula from the patients heart; and supplyingblood to tissue downstream of the located damage via the first conduitcoupler and the second conduit coupler.

[0029] Other objects, features and advantages will be apparent topersons skilled in the art from the following detailed description ofthe invention and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The invention may be understood more readily by reference to thefollowing drawings.

[0031]FIG. 1 depicts a surgical table and the positioning of a patienton such a surgical table.

[0032]FIG. 2 depicts the sub-costal incision into the patient's chest tothe left of the midline.

[0033]FIG. 3 depicts retraction of the incision with the retractors anda fulcrum device in place.

[0034]FIG. 4 depicts a close view through the fulcrum device and intothe retracted incision.

[0035]FIG. 5 depicts the fulcrum device.

[0036]FIG. 6 is a view inside the chest through the fulcrum device withthe heart blade in place.

[0037]FIG. 7 depicts a partially cutaway, perspective view of thepatient's chest cavity

[0038]FIG. 8 depicts an endoscope holding device with the endoscope inplace.

[0039]FIG. 9 depicts the endoscope and the endoscope holding device.

[0040]FIG. 10 depicts the endoscope and a dissecting instrumentpositioned through the fulcrum device into the chest cavity.

[0041]FIG. 11A depicts a dissecting instrument, and FIGS. 11B and 11Cdepict enlarged views of the tip of the dissecting instrument of FIG.11A and illustrate the multiple functions of an embodiment of thedissecting instrument.

[0042]FIG. 12 depicts the dissecting instrument grasping a branch of theInternal Mammary Artery

[0043]FIG. 13 depicts a partially cutaway, side perspective view of thepatient's chest with the cannula in place.

[0044]FIG. 14 depicts the positioning of the cannula in the heart.

[0045]FIG. 15A depicts the manipulation and attachment features of thecannula, and FIG. 15B depicts the entire cannula outside of thepatient's heart. FIG. 15C depicts the portion of cannula between thecannula tip and the suction cup with both cannula balloons inflated.FIG. 15D shows a cross-sectional view of the proximal balloon of FIG.15C. FIG. 15E depicts the cannula tip and the distal balloon andindicates the relative positions of the distal and radial dischargeopenings.

[0046]FIG. 16A depicts a pair of cardiac scissors, and FIG. 16B depictsand enlarged view of the tip of the cardiac scissors of FIG. 16A.

[0047]FIG. 17 depicts a coupler with the tissue clamp in a relaxedstate.

[0048]FIGS. 18A and 18B depicts the vessel connection devices as thetissue clamp deploys.

[0049]FIG. 19 depicts a coupler after a tissue clamp is heated to itstransition temperature.

[0050]FIG. 20 depicts a coupler with complementary mating surface.

[0051]FIG. 21 depicts a conduit coupling device connecting two conduits.

[0052]FIG. 22 depicts a clamping ring in a martensitic state.

[0053]FIG. 23 depicts a clamping ring that is heated to its transitiontemperature.

[0054]FIG. 24 depicts a clamping ring with teeth and holes.

[0055]FIG. 25 depicts a clamping ring.

[0056]FIGS. 26A-26D depict anastomotic applications of the conduitcoupling device with conduits of varying condition.

[0057]FIG. 27 depicts a ring clamp device for use with the conduitcoupling device of the present invention.

[0058]FIG. 28 depicts a top view of a coupler according to an embodimentof the present invention.

[0059]FIG. 29 depicts a view of coupler positioned in and secured to aconduit.

[0060]FIG. 30 depicts the connector holding device.

[0061]FIG. 31A depicts an embodiment of a coupler holder and deliverydevice, and FIG. 31B depicts an enlarged view of the tip of the couplerholder and delivery device of FIG. 31A.

[0062]FIG. 32 depicts a distal end of coupler holder and delivery deviceof FIG. 31.

[0063]FIG. 33 depicts the coupler held in position prior to delivery toa conduit by coupler holder and delivery device of FIG. 31A.

[0064]FIG. 34 depicts the coupler immediately after release from thecoupler holder and delivery device of FIG. 31A into its final positionin the conduit.

[0065]FIGS. 35A-35D depicts a sequence of steps in the placement of thevessel connector in one vessel.

[0066]FIGS. 36A and 36B depict a sequence of steps in the placement ofthe vessel connector in a second vessel.

[0067]FIG. 37 depicts the device used to connect the vessel connectors.

[0068]FIGS. 38A-38C depict a sequence of steps in the connecting of thetwo vessels.

[0069]FIG. 39A depicts an external view of the final connected vessels,and FIG. 39B depicts a cross-sectional view of the final connectedvessels.

[0070]FIG. 40 depicts the final vessel connection in the body.

[0071]FIG. 41 depicts the final wound on the patient.

DETAILED DESCRIPTION OF THE DRAWINGS PATIENT POSITIONING

[0072] A patient 1000 is positioned on the a surgical table 200, asshown in FIG. 1. The surgeon (not shown) stands between the legs 1010 ofpatient 1000. Patient's legs 1010 are spread apart and rest on a pair ofsupports 210. A sub-costal incision 1020, as shown in FIG. 2, is madebelow the ribs on the left side of patient 1000 and extends for aboutsix centimeters from the midline of patient 1000 outwards. The surgicaltable also may comprise a video monitor 200 and a camera (not shown),whereby images of the patient's chest cavity are displayed on the videomonitor. Video monitor 220 is positioned just above patient 1000 forready viewing by the surgeon.

[0073] Incision Retraction

[0074] Incision 1020 then is opened, e.g., spread or separated, as shownin FIG. 3, by means of two retractor blades 12 a and 12 b. Upperretractor blade 12 a connects to a vertical bar 10 a, which is attachedto surgical table 200. A first mounting bracket 13 a permits verticalmovement of upper retractor blade 12 a to increase or decrease the bladeretraction. Similarly, lower retractor blade 12 b attaches through asecond vertical bar 10 b to surgical table 200 through a second mountingbracket 13 b. Second mounting bracket 13 b also permits verticalmovement of lower retractor blade 12 b to increase or decrease the bladeretraction. Retractor blades 12 a and 12 b engage a fulcrum device 14,as shown in FIG. 4. Fulcrum device 14 may be sized to correspond to thesize of incision 1020 and is placed into incision 1020 to maintain awindow-like opening 15 to the patient's chest. Upper retractor blade 12a passes through upper fulcrum slot 140 a and lower retractor blade 12 bpasses through lower fulcrum slot 140 b. Referring to FIG. 5, upperretractor blade 12 a is equipped with an upper grasping bare 120 a toengage upper fulcrum slot 140 a, lower retractor blade 12 b is equippedwith a lower grasping bar 120 b to engage lower fulcrum slot 140 b.

[0075] Fulcrum Device

[0076] Fulcrum device 14 in FIGS. 4 and 5 contains a perimeter lip 16that runs around fulcrum device 14 and, in an embodiment of theinvention, may give fulcrum device 14 a substantially elliptical shape.The tissue on either side of incision 1020 is captured in perimeter lip16. Fulcrum device 14 has two parallel, first rails 17 a and 17 b, whichextend across window-like opening 15. An instrument support 18 comprisestwo parallel, second rails 19 a and 19 b; a pair of first graspingrunners 20 a and 20 b, to which the ends of second rails 19 a and 19 bare joined; and an instrument port 21 having an instrument accessorifice formed therethrough and a pair of second grasping runners 22 aand 22 b which slidably engage second rails 19 a and 19 b. Surgicalinstruments, such as those described herein, may be passed through theinstrument access orifice and into the patient's chest. First graspingrunners 20 a and 20 b slidably engage first rails 17 a and 17 b,respectively, so that instrument support 18 may be moved perpendicularto a first axis X of fulcrum device 14. Similarly, second graspingrunners 22 a and 22 b slidably engage second rails 19 a and 19 b,respectively, so that instrument port 21 may be moved perpendicular to asecond axis Y of fulcrum device 14. Thus, instrument port 21 may bepositioned at almost any location within window-like opening 15. Secondrails 19 a and 19 b may be joined to first grasping runners 20 a and 20b or formed integrally with first grasping runners 20 a and 20 b to forminstrument support 18.

[0077] Second grasping runners 22 a and 22 b may operate when squeezedtowards each other to release instrument port 21 to move vertically onthe second rails 19 a and 19 b. Friction may keep instrument support 18from moving laterally along the first rails 17 a and 17 b.

[0078] Fulcrum device 14 also may comprise a light transmitting cord 23,such as a fiber optic cable or cables, which is attached to a lightsource (not shown). Cord 23 is connected to fulcrum device 14 throughconnector 24. Light transmitted by cord 23 and is supplied to one ormore emitters 25, which emitters 25 may be arrayed around the side offulcrum device 14 facing the patient's chest cavity. Thus, emitters 25may supply sufficient light inside the chest cavity for visualization ofthe surgical site or sites by the surgeon or by a camera fortransmission to and display on monitor 220. For example, emitters 25 maybe the ends of fiber optic cables. In another embodiment of theinvention, however, cord 23 and connector 24 may be replaced with apower cable and emitters 25 may be light emitting diodes (LEDs) or otherlight emitting electrical or electronic devices.

[0079] Heart Blade

[0080] Referring to FIG. 6, a heart blade 30 may be passed through lowerfulcrum passage 26 in fulcrum device 14. Heart blade 30 may be usedposition the patient's heart, e.g., to push the heart down, while thesurgeon operates inside the patient's chest cavity. This use of heartblade 30 may provide more space within the cavity. By pulling upward onhear blade 30, as shown by arrow A moves the distal end of heart blade30 downward, as shown by arrow B.

[0081] In FIG. 7, a partially cutaway, perspective view of the patient'schest cavity is depicted. In this view, heart blade 30 is shown pushingdownward on the patient's heart 1030 in accordance with the depiction inFIG. 6.

[0082] Endoscope Holder

[0083] As shown in FIG. 8, an endoscope 40 equipped with a camera 50 maybe used to visualize the inside of the patient's chest cavity. Imagescaptured by camera 50 may be displayed on monitor 220. Endoscope 40 maybe inserted into the patient's chest cavity through window-like opening15 in fulcrum device 14. An endoscope holding device 42 may be used bythe surgeon to manipulate endoscope 40 in a desired position. Anendoscope stabilizing device 44, which may be used to stabilizeendoscope 40 within the patient's body during surgery, may be attachedto one of the vertical bars, such as second vertical bar 10 b, ofsurgical table 200.

[0084] An embodiment of endoscope 40 including camera 50 is depicted inFIG. 9. Endoscope stabilizing device 44 secures the shaft of endoscope40 to second vertical bar 10 b. A knob screw 44′ helps secure endoscopestabilizing device 44 to second vertical bar 10 b.

[0085] The shaft of endoscope 40 passes through a first ball joint 45and a handle 46. Handle 46 is equipped with a mechanism for applyingfriction to the shaft of endoscope 40 to prevent the shaft of endoscope40 from moving in and out. First ball joint 45 comprises a first ball 45a and a first socket 45 b, which is engaged first ball 45 a. Amanipulating shaft 47 rides in and out of endoscope holding device 42,and a second ball joint 48 supports manipulating shaft 47 and ridesinside second socket 47 b. Second ball joint 48 comprises second ball 48a and second socket 48 b. Generally, first ball joint 45 and second balljoint 48 are fixed in position by the surgeon, whereby first ball 45 aand second ball 48 a engage or are engaged by first socket 45 b andsecond socket 48 b, respectively, to hold endoscope 40 in a desiredposition.

[0086] In a preferred embodiment, when an activating lever 49 isdepressed, each of ball joints 45 and 48 are unencumbered, such thatfirst ball 45 a and second ball 48 a may move freely within first socket45 b and second socket 48 b, respectively. For example, when activatinglever 49 is depressed; mechanical, electrical, or electromagneticsignals, or the like, may be transmitted via handle 46 and manipulatingshaft 47 to actuate one, either, or both of ball joints 45 and 48.Consequently, the surgeon may manipulate endoscope 40 freely withrespect to manipulating shaft 47, and endoscope 40 may be moved to anyposition in space. When the lever 45 is released, each of the balljoints locks into position and holds endoscope 40 in the desiredposition.

[0087] Dissecting Instrument

[0088] A dissecting instrument 60 of FIG. 10 may be used together withendoscope 40 in surgical procedures on patient 1000. As shown in FIG.10, both the dissecting instrument 60 and endoscope 40 may enter thepatients chest cavity through window-like opening 15 of fulcrum device14. In particular, however, dissecting instrument 60 may be insertedinto the patient's chest cavity through the instrument access orifice ofinstrument port 21.

[0089] Referring to FIG. 11A, dissecting instrument 60 comprises ahandle 61, shaft 65, and tip 69. Tip 69 comprises dissecting means.Dissecting instrument 60 may perform at least three separate functions:first, blunt dissection with spatula-shaped tip 69; second, injection ofCO₂ at the distal end to separate tissue planes; and third, coagulationand cutting by RF energy. Shaft 65 and tip 69 are rotatable by means ofrotation control knob 62. Moreover, a distal end 66 of shaft 65 may bepivotable at a shaft joint 67. A first slidable button 63 may beprovided on handle 61 to articulate distal end 66 about shaft joint 67.

[0090] As noted above, dissecting instrument 60 may be used to performmultiple functions. Referring to FIGS. 11B and 11C, enlarged views oftip 69 are depicted. A spatula end 690 affixed to spatula end shaft 691may be used as a blunt dissector. A second slidable button 64 on handle61 may be actuated to move a grasper jaw 693 into and out of contactwith spatula end 690. For example, when second slidable button 64 onhandle 61 is actuated; mechanical, electrical, or electromagneticsignals, or the like, may be transmitted via shaft 65 to move a grasperjaw 693 into and out of contact with spatula end 690. Handle 61 also maybe equipped with means for conveying CO₂ and RF energy to tip 69. Forexample, a CO₂ connection 68 a in handle 61 may be connected to a supplysource for CO₂. CO₂ may be passed from the CO₂ connection 68 a throughdissecting instrument 60 to a CO₂ outlet tube 692 located in tip 69.When tip 69 is properly positioned and the flow of CO₂ is activated, CO₂is injected into the patient's tissue, which is engaged at the distalend of tip 69 of dissecting instrument 60. The flow of CO₂ enables thesurgeon to separate tissue into natural tissue planes. In this way, thevessel being dissected is more easily identified and dissected out ofthe tissue.

[0091] As noted above, dissecting instrument 60 also may utilize RFenergy in the removal of a vessel. For example, an RF connection 68 b inhandle 61 may connect dissecting instrument 60 to a known RF energyconsole. If a blood vessel is encountered requiring coagulation, e.g.,cauterization, the surgeon may manipulate second slidable button 64 onhandle 61 to grasp the vessel between spatula end 690 and grasper jaw693. The surgeon then may apply RF energy to the vessel in order to sealthe vessel. Once the vessel has been sealed, the surgeon again maymanipulate second button 64 to move grasper jaw 693 away from spatulaend 690 and placing the sealed vessel in direct contact with the edge ofspatula end shaft 691. With the exception of a narrow strip along itsinnermost surface, the contacting edge of spatula end shaft 691 iselectrically insulated along its length. When the RF energy is appliedto this spatula end shaft 691, the RF energy is focused onto thevessel's tissue along this narrow, un-insulated strip and the tissue iscut by the RF energy, thereby severing the sealed vessel into twoportions.

[0092] Use of dissecting instrument 60 is shown in FIG. 12. Dissectinginstrument 60 is shown grasping a blood vessel 1040 which is a branch ofthe Internal Mammary Artery (IMA) 1045. The vessel 1040 is graspedbetween spatula end 690 and grasper jaw 693, and RF energy then may beapplied to coagulate blood within the vessel.

[0093] Left Ventricular Cannula

[0094] A partially cutaway, side perspective view of the chest is shownin FIG. 13. An Left Ventricular (LV) cannula 70 is a catheter and heartmanipulation device. Cannula 70 may be used to deliver blood to theaorta or cardioplegia solution to the coronary arteries, or both, duringCPB.

[0095] Referring to FIG. 14, a cross-section of heart 1030 is shown withLV cannula 70 in place. LV cannula 70 is positioned with a cannula tip71 in the ascending aorta 1033. A distal balloon 72 is inflated in theaorta 1033 to seal the aorta 1033 and stabilize cannula tip 71. A secondballoon 73 is positioned inside the left ventricle 1034 and serves tocenter cannula 70 within the left ventricle 1034. LV cannula 70 isattached to the heart 1030 via a suction cup 77 affixed on the leftventricular apex 1035. The surgeon may employ a manipulator arm 76attached to suction cup assembly 77 to manipulate the heart 1030 duringsurgery, in particular, to gain access behind the heart 1030. Cathetertubing 75 exits the heart 1030 through suction cup assembly 77. Cathetertubing 75 may be attached to CPB machinery or other knowncardiopulmonary support systems. Oxygenated blood may be pumped from CPBmachinery, through catheter tubing 75 and out the cannula tip 71, assuch blood is delivered to patient 1000. In addition, cardioplegiasolution which is used to stop the heart from beating may be pumped fromoutside patient 1000, through one of catheter tubes 75. Suchcardioplegia solution exits the cannula from holes 78 located distal tothe aortic valve, but proximal to distal balloon 72 to enter thecoronary arteries in the coronary sinus.

[0096] LV cannula 70 comprises two components: a stabilizer andmanipulation component 700 depicted in FIG. 15a and a catheter component710 added in the depiction of FIG. 15b. Stabilizer and manipulationcomponent 700 is introduced through an incision made in the apex 1035 ofthe heart 1030, for example, using either a scalpel or a trocar.Stabilizer and manipulation component 700 comprises a stabilizer shaft80, which penetrates through the wall of the apex 1035 of the leftventricle 1034 and into the left ventricle 1034. The surgeon may applysuction to suction cup 77 through a suction tube 81. The suction istransferred through holes on the inside of suction cup 77 and drawssuction cup 77 onto the muscle tissue of the left ventricle 1034. Ahandle 79 is pivotally mounted to stabilizer and manipulation component700, and the surgeon may employ handle 79 to manipulate cannula 70 and,therefore, the heart 1030. Stabilizer and manipulation component 700further may comprise a hemostatic valve 82 which permits passage of adevice through suction cup 77 of cannula 70, but limits blood flow backthrough valve 82.

[0097] Once stabilizer and manipulation component 700 has been applied,the surgeon may pass catheter component 710, as shown in FIG. 15B,through stabilizer and manipulation component 700 and through the leftventricle 1034 until cannula tip 71 rests in the ascending aorta 1033.The surgeon may pass catheter component 710 through hemostatic valve 82which seals around catheter component 710 and prevents leakage of blood.

[0098] Proximal balloon 73 serves to center catheter component 710 inthe left ventricle 1034 and also to limit any movement of cathetercomponent 710 linearly. A cross-sectional view of proximal balloon 73 isdepicted in FIG. 15D. The shaft of catheter component 710 passes througha lumen 730 formed within proximal balloon 73. Proximal balloon 73 maybe bonded to the shaft along the center of lumen 730 of proximal balloon73 at an interior surface 731. Thus, proximal balloon 73 is free to moveat its ends 732. This design permits the shaft limited axial movement,as shown by double-headed arrow C of FIG. 15C. Such axial movement isnecessary because, as oxygenated blood is injected through cathetercomponent 710 into the aorta 1033, a hydraulic force is created pushingcatheter component 710 towards the heart 1030.

[0099] Such oxygenated blood exits catheter component 710 at a distaldischarge opening 83 in FIG. 15E. Distal discharge opening 83 is angledto deflect the blood away from the aorta 1033 and, thereby, to avoiddirect jetting of blood against the aorta walls. Unlike oxygenatedblood, cardioplegia solution exits catheter component 710 from radialdischarge openings 78 adjacent to proximal balloon 72.

[0100] Tissue Scissors

[0101] Referring to FIGS. 16A and 16B, a scissors 90 may be used by thesurgeon to dissect tissue or to cut an incision into a vessel to allowplacement of a coupler. Scissors 90 also may be used as an alternativeto dissecting instrument 60 of FIGS. 11A-11C. A scissors handle 99 isattached to a scissors shaft 291. A distal end 93 of scissors 90 isadapted to pivot about a distal end joint 94 by manipulating a slidablebutton 97. Scissors 90 may be equipped with two counter acting scissorblades 95 and 96 at its distal end. An inner shaft (not shown) may betranslated by manipulation of a handle ring 98. The manipulation of ring98 further manipulates either or both of scissor blades 95 or 96. Forexample, when ring 98 is manipulated; mechanical, electrical, orelectromagnetic signals, or the like, may be transmitted via scissorsshaft 291 to move either or both of scissor blades 95 or 96 into contactwith each other. In still another embodiment of such scissors, scissors90 may be adapted to employ RF energy if a blood vessel is encounteredrequiring coagulation, e.g., cauterization. Similar to the forgoingdescription of dissecting instrument 60 of FIG. 11A, an RF connection900 in handle 99 may connect at least one of scissor blades 95 and 96 ofscissors 90 to a known RF energy console.

[0102] Vascular Connections

[0103] As shown in FIGS. 17-20, a coupler 100 according to an embodimentof the present invention comprises a saddle 101 for positioning within aconduit and a channel 102 for directing fluid from the conduit throughcoupler 100. Coupler 100 further comprises a tissue clamp 103 forsecuring the conduit to saddle 101, a flange 106 for positioning inalignment with a flange 106 of another coupler 100, and a mating surface107, 107′ for attachment to a mating surface 107, 107′ of anothercoupler 100.

[0104] Saddle 101 has a substantially elliptical cross-section and maybe positioned within a conduit. As shown in FIG. 29, saddle 101 may beconfigured with a curvature that is the same as, or substantiallysimilar to, a curvature of the inner and outer surfaces of conduit 190in which saddle 101 may be positioned. The curvature of saddle 101 maybe varied depending upon the curvature of conduit 190, so that an areaof contact between saddle 101 and conduit 190 may be increased or sothat conduit 190 may not be distorted by placement of saddle 101 withinconduit 190, or both.

[0105] Saddle 101 may be positioned within a conduit by making anincision at a desired location along conduit 190. The length of theincision may be less than a length of the longest axial dimension ofsaddle 101. Saddle 101 then may be inserted through the incision intoconduit 190. Conduit 190 may stretch slightly to fit over the edges ofsaddle 101 as saddle 101 is positioned within conduit 190.

[0106] Saddle 101 transitions to a channel 102, which may be formedintegrally with saddle 101, as shown in FIG. 17. When saddle 101 ispositioned within conduit 190, channel 102 remains entirely orsubstantially outside of conduit 190, as shown in FIG. 29. Channel 102forms a flow path for fluid in conduit 190 to flow through coupler 100.As shown in FIG. 28, an inner surface of channel 102 transitions from asubstantially elliptical cross-sectional area 102 a to a substantiallycircular cross-sectional area 102 b.

[0107] In one embodiment of the invention, the cross-sectional area ofchannel 102 remains substantially constant as the inner surface ofchannel 102 transitions from an area of substantially ellipticalcross-section 102 a to an area of substantially circular cross-section102 b. This configuration improves the ability of channel 102 to directfluid through coupler 100 at a substantially constant velocity or rate,or both, with a minimum of disturbances in the fluid flow. In addition,the cross-sectional area of each channel 102 may correspond to thecross-sectional area of a conduit in which coupler 100 may bepositioned, so that the velocity or rate, or both, of fluid flowing fromconduit 190 through coupler 100 may remain substantially constant. Inanother embodiment of the invention, the cross-sectional area of channel102 may increase or decrease as channel 102 transitions from an area ofsubstantially elliptical cross-section 102 a to an area of substantiallycircular cross-section 102 b, so that coupler 100 may be used to connectconduits 190 of different cross-sectional areas.

[0108] A flange 106 and a mating surface 107, 107′ may be formed at anend of channel 102. For example, flange 106 may be formed along an outersurface of channel 102, adjacent to a portion of channel 102 having asubstantially circular cross-section, as shown in FIGS. 17-20. Flange106 and mating surface 107, 107′ enable a pair of couplers 100 to besecured together to form a conduit coupling device according to thepresent invention for connecting two conduits. By positioning flange 106and mating surface 107, 107′ of one coupler 100 in alignment with flange6 and complementary mating surface 107, 107′ of another coupler, asshown in FIG. 21, two conduits may be placed in fluid communication. Inone embodiment of the invention, mating surfaces 107, 107′ may comprisecomplementary indented and protruding stepped portions that may beformed on respective flanges 106 of a pair of couplers 100.

[0109] The connector is shown in more detail in FIGS. 18A and 18B. Eachconnector comprises saddle 101, tissue clamp 103, and flange 106. Tissueclamp 103 maybe made from a superelastic material, such as nitinol.Tissue clamp 103 may be held by the delivery device, such that tissueclamp 103 is pulled back from saddle 101 to permit saddle 101 to beintroduced into the vessel. Once saddle 101 is introduced into thevessel, tissue clamp 103 is released and springs into the position shownin FIG. 18B.

[0110] Tissue clamp 103 may be positioned around channel 102. Tissueclamp 103 remains outside of conduit 190. Tissue clamp 103 may compriselegs 104 and a plurality of holes 105. Holes 105 may be formed throughtissue clamp 103. Holes 105 improve the connection between tissue clamp103 and tissue of conduit 190, thereby securing conduit between tissueclamp 103 and saddle 101. Holes 105 may be dimpled, as shown in FIGS. 19and 20, so that holes 105 protrude toward and into tissue of conduit 190to improve further the connection between tissue clamp 103 and conduit190. In addition, tissue may grow through holes 105, further securingtissue clamp 103 and coupler 100 to conduit 190. In another embodimentof the invention, a plurality of teeth 109 may be positioned along aperiphery of tissue clamp 103 to engage tissue of conduit 190, therebysecuring conduit 190 between tissue clamp 103 and saddle 101. In afurther embodiment of the invention, tissue clamp 103 may include aplurality of holes 105 and teeth 109, as shown in FIG. 24.

[0111] Tissue clamp 103 may be formed of a shape-memory alloy, such as anickel titanium alloy or the like. The transition temperature of theshape-memory alloy may be selected to be a temperature that is at orslightly above body temperature, such as 38° C. for humans. Therefore,tissue clamp 103 may be ductile and easily shaped at room temperature inits martensitic state. In one embodiment of the invention, tissue clamp103 may be shaped into a substantially flat form in its martensiticstate, as shown in FIGS. 17 and 22, and tissue clamp 103 may bepositioned adjacent to flange 106 of coupler 100. This configurationenables saddle 101 of coupler 100 to be positioned within a conduitwithout tissue clamp 103 interfering with the positioning of saddle 101.

[0112] Tissue clamp 103 maintains its martensitic state shape untiltissue clamp 103 is heated to its transition temperature, which in oneembodiment of the invention may be selected to be a temperature that isat or above human body temperature. Once tissue clamp 103 is heated toits transition temperature, tissue clamp 103 transforms, i.e., returnsto a predetermined shape, which may be a shape shown in FIGS. 19, 20,and 23, in which tissue clamp 103 secures a conduit between tissue clamp103 and saddle 101. Tissue clamp 103 may have a predetermined shape inwhich legs 104 of tissue clamp 103 extend and sides of tissue clamp 103curve upward and assume a substantially elliptical curved shape tosecure conduit 100 between tissue clamp 103 and saddle 101, as shown,for example, in FIG. 29. Each leg 104 of tissue clamp 103 may extenddownwardly in a direction that is generally away from the direction inwhich sides of tissue clamp 103 curve upwardly, so that each leg 104 maycontact flange 106 and force sides of tissue clamp 103 upwardly towardsaddle 101, thereby securing a conduit between tissue clamp 103 andsaddle 101.

[0113]FIG. 21 shows a conduit coupling device according to an embodimentof the invention. According to this embodiment of the invention, conduitcoupling device comprises a pair of couplers 100 and a clamp 108.Couplers 100 may include complementary mating surfaces 107, 107′. In oneembodiment of the invention, conduit coupling device may be used toconnect conduits 190, 191 that extend substantially parallel to oneanother in the same or in a substantially similar plane, as shown inFIG. 21. An incision may be made in each conduit 190, 191, so that asaddle 101 of each coupler 100 may be positioned within a respectiveconduit 190, 191. Each tissue clamp 103 may be heated to its transitiontemperature, so that each tissue clamp 103 transforms to itspredetermined shape to secure a respective conduit 190, 191 between arespective tissue clamp 103 and saddle 101. Thus, each coupler 100 maybe positioned in fluid communication with a respective conduit 190, 191.

[0114] Once each coupler 100 is secured to a respective conduit 190,191, respective flanges 106 and mating surfaces 107, 107′ of eachcoupler 100 may be positioned in alignment, as shown in FIG. 21. Aclamping ring 108 may be positioned around a flange 106 of each coupler100 and couplers 100 may be secured together by crimping clamping ring108 around flanges 106.

[0115] As shown in FIG. 25, clamping ring 108 may be formed with lips108 a, 108 b that may be seated around an edge of each respective flange106 of coupler 100, thereby securing flanges 106 and respective couplers100 together. Clamping ring 108 may be made from a metal such as steel,titanium, a nickel titanium alloy, or the like.

[0116] In one embodiment of the invention, couplers 100 may bepositioned in and secured to respective conduits 190, 191 before flanges106 of each coupler 100 may be positioned in alignment and secured byclamping ring 108. In another embodiment of the invention, a pair ofcouplers 100 may be secured together at their respective flanges 106 byapplication of clamping ring 108 before saddle 101 of each coupler 100is positioned in and secured to a respective conduit 190, 191. Forexample, flange 6 of each coupler 100 may be secured by clamping ring108 before saddle 101 of each coupler 100 is positioned in and securedto each conduit 190, 191. In a further embodiment of the invention, apair of couplers 100 may be welded, glued, or otherwise joined togetherat respective flanges 106. In a still further embodiment of theinvention, a pair of couplers 100 may be welded, glued, or otherwisejoined together, eliminating flanges 106, or a pair of couplers 100 maybe manufactured integrally as a single unit.

[0117] In still further embodiments of the invention, a conduit couplingdevice may be manufactured from a pair of couplers 100 that may bepositioned at various, predetermined angles and orientations relative toone another, so that the conduit coupling device may be used to connectconduits that may be positioned at various angles and orientations toone another.

[0118] Clamping ring 108 may be applied to flanges 106 of each coupler100 with a ring clamping device 150, shown in FIG. 27. Ring clampingdevice 150 may include arms 151, 153. A lip 154, 155 may be positionedat a distal end of each arm 151, 153. Clamping ring 108 may bepositioned within arms 151, 153 of ring clamping device 150, so that arespective lip 154, 155 of each arm 151, 153 contacts and engages arespective end of clamping ring 108 to retain clamping ring within ringclamping device 150.

[0119] Ring clamping device 150 may be actuated, such that arms 151, 153move outwardly and inwardly relative to one other. In an embodiment ofthe invention shown in FIG. 28, arm 151 may pivot about a pivot point156 and move outwardly and inwardly relative to arm 153, which may besecured to or otherwise formed integrally with a body of ring clampingdevice 150. In another embodiment of the invention (not shown), botharms 151, 153 may pivot about respective pivot points 156 and moveoutwardly or inwardly relative to one another. In a further embodimentof the invention (not shown), both arms may move in a radial directionrelative to the body of ring clamping device 150 and move toward andaway from one another.

[0120] In each embodiment of the invention, clamping ring 108 may bepositioned within ring clamping device 150, such that a lip 154, 155 ofeach arm 151, 153 contacts a respective end of clamping ring 108. Ringclamping device 150 may be actuated such that arms 151, 153 move awayfrom one another. As arms 151, 153 move away from one another, lips 154,155 pull each respective end of clamping ring 108 apart, therebyexpanding clamping ring 108 outwardly. Ring clamping device 150 may thenposition clamping ring 108 around flanges 106 of a pair of couplers 100that may be positioned in alignment. Ring clamping device 150 may bere-actuated, so that arms 151, 153 move toward one another, therebycrimping clamping ring 108 securely around flanges 6 of each coupler 100to secure couplers 100 together to form a conduit coupling device. Asarms 151, 153 move toward one another, lips 154, 155 disengage fromrespective ends of clamping ring 108 and release clamping ring 152. Onceclamping ring 108 has been crimped around flanges 106 of each coupler100, clamping ring provides a permanent junction retaining each coupler100 in alignment and position.

[0121] In an embodiment of the invention in which couplers 100 may beconnected to form a conduit coupling device between conduits ofsubstantially similar cross-sectional area, each coupler 100 may beconfigured with a channel 102 the cross-sectional area of which isconstant or substantially constant. Each coupler 100 may be configuredwith a cross-sectional area that is the same as or substantially similarto that of another coupler 100 and to the cross-sectional areas of eachrespective conduit. Thus, a conduit coupling device formed according tothis embodiment of the invention may be used to connect two conduits ofthe same or substantially similar cross-sectional area and to maintain aconstant or substantially constant cross-sectional flow area from oneconduit to the other conduit. By maintaining the same or a substantiallyconstant cross-sectional flow area, a conduit coupling device accordingto this embodiment of the invention may reduce or eliminate flowdisturbances and velocity or rate changes in fluid flowing from oneconduit through conduit coupling device to another conduit, so that theflow of fluid and elements suspended therein, such as blood cells or thelike, may not be disrupted unnecessarily. In addition, clottingmechanisms may not be activated as may occur when fluid flow patternschange.

[0122] In another embodiment of the invention in which couplers 100 maybe connected to form a conduit coupling device between conduits havingdifferent cross-sectional areas, each coupler 100 may be configured witha channel 102 the cross-sectional area of which transitions between thedifferent cross-sectional areas of the conduits to be connected. Forexample, a first coupler 100 may be configured with an ellipticalcross-sectional area that is the same as or substantially similar to thecross-sectional area of the conduit in which a saddle 101 of firstcoupler 100 may be positioned. A second coupler may be designed with anelliptical cross-sectional area that is substantially similar to thecross-sectional area of the second conduit in which a saddle 101 of thesecond coupler 100 may be positioned. As the channel 102 of each coupler100 transitions from a substantially elliptical cross-sectional area toa substantially circular cross-sectional area, the cross-sectional areaof each channel 102 may increase or decrease, such that thecross-sectional areas of each channel 102 are the same or substantiallysimilar adjacent to flanges 106 of each coupler 100. In this way,conduits of different cross-sectional area may be connected whilereducing or eliminating disruptions in the flow of fluid from oneconduit to another conduit, via conduit coupling device. Because thecross-sectional configuration of each channel 102 of each coupler 100may be substantially circular at flange 106, couplers 100 may be rotatedrelative to one another around their centerline axes 115, so thatcouplers 100 may be used to connect conduits that may be positionedtransversely to one another, as shown, for example, in FIG. 26C.

[0123] Coupler 100 may be fabricated from a variety of materials. Forexample, coupler 10 may be fabricated of a polymer, such aspolytetrafluoroethylene, PEEK, polycarbonate, polyurethane,polypropylene, nylon, or the like. An advantage of polymers is that suchmaterials may be relatively inert and therefore less likely to causeclotting in fluid such as blood than other materials. Also, polymers maybe fabricated to include additives, such as biochemical agents, that maydissipate over time into surrounding tissues. Additives may includeanti-platelet agents, anti-smooth muscle cell growth factors,anti-inflammatory agents, anti-fibrin agents, and anti-thrombin agents.Use of these agents may improve the patency rate of conduit couplingdevices placed inside blood vessels by limiting biologic reactions ofbody tissue and conduits to the implanted devices.

[0124] In other embodiments of the invention, couplers may be fabricatedof metal, such as stainless steel, nickel titanium alloy, or the like.An advantage of such metals is their higher strength compared to othermaterials, enabling metal couplers to be fabricated with a wallthickness that is less than a thickness of couplers made of othermaterials. Metal couplers may have a wall thickness of about 7.87×10⁻⁵mm (0.002 inches) to about 19.69×10⁻⁵ mm (0.005 inches). Fluidcontacting surfaces of metal couplers may be coated with one or morepolymers such as silicone or polyurethane to limit the reaction of fluidand tissue to the implant. In turn, these coatings may includebiochemical agents described above that may improve the biocompatibilityof couplers with conduits and other body tissue.

[0125] In a preferred embodiment, tissue clamps 3 may be made ofnitinol. Moreover, suitable nitinol may be heat treated, such that itsaustenitic transition temperature is well below room temperature, forexample, at about 10° C., and such nitinol may be in its superelasticstate at room temperature. Consequently, tissue clamps 103 made fromsuch nitinol may be inserted into a holder and delivery device 160, asdescribed below with respect to FIGS. 31-34, by simply bending thenitinol tissue clamps into position. When such tissue clamps arereleased by device 160 at a temperature above room temperature, suchtissue clamps spring into their original (pre-bent) shape.

[0126] In operation, a coupler 100 may be positioned in a conduit 190 bymaking an incision at a desired location. The length of the incisionpreferably is less than the longest axial dimension of saddle 101.Saddle 1 then may be inserted through the incision into conduit 190.Conduit 190 stretches slightly over edges of saddle 101. The curvatureof saddle 101 is adapted to match the inside radius of conduit 190, sothat conduit 190 may not be distorted by saddle 101. Saddle 101 may beconfigured with different radii of curvature to fit conduits ofdifferent inner radii. Tissue clamp 103 remains outside conduit 190.

[0127] Once coupler 100 is positioned inside conduit 190, tissue clamp103 may be heated to its transition temperature using a warm solution,eg., a sterile saline solution. The transition temperature preferably isa temperature that is at or above a human body temperature. When tissueclamp 103 is heated to its transition temperature, tissue clamp 103returns to a predetermined shape, which may be a shape as shown in FIGS.20 and 29, that secures conduit 190 between tissue clamp 103 and saddle101. If tissue clamp 103 is made of nitinol, once coupler 100 ispositioned inside conduit 190, tissue clamp 103 may be released as itstransition temperature is at about 10° C., a temperature that is wellbelow, for example, human body temperature. When nitinol tissue clamp103 is released, tissue clamp 103 returns to a predetermined shape,which may be the shape as shown in FIGS. 20 and 29, that secures conduit190 between tissue clamp 103 and saddle 101. Dimples 105 or teeth 109,or both, may be formed on tissue clamp 103 to enhance the contactbetween tissue clamp 103 and conduit 190. Two conduits may be connectedby placing a coupler 100 within each conduit and connecting the couplers100 at their respective flanges 106 to form a conduit coupling device,as shown for example in FIG. 21.

[0128] As shown in FIGS. 26A-26D, a conduit coupling device formed froma pair of couplers 100 may be used to form various connections betweenconduits. As shown in FIG. 26A, a side-to-side connection or anastomosismay be formed by connecting a first conduit 190 to a second conduit 191to bypass a blockage 195 in second conduit 191. A coupler 100 may bepositioned in, and secured to, a respective conduit 190, 191. A flange106 of each coupler 100 may be aligned and secured by a clamping ring108 (not shown). A distal end of first conduit 190 may be closed using afastener 193, such as a clip, suture, clamp or the like, to prevent flowof fluid through distal end. As illustrated by arrows in FIG. 26A, fluidmay flow from first conduit 190, through couplers 100 to a distal end ofsecond conduit 191, thereby bypassing blockage 195.

[0129] In another embodiment of the invention, couplers 100 may beconfigured to form a conduit coupling device that connects conduits thatmay be transverse to one another, as shown in FIG. 26B. This embodimentenables couplers to form a conduit coupling device that connects bloodvessels that may lie at varying angles to one another in the body. Forexample, an end-to-side anastomotic connection may be made by placing afirst coupler 100′ in a distal end of a first conduit 190 and a secondcoupler 100 in a second conduit 191 to form a conduit coupling devicethat bypasses a blockage 195 in second conduit 191. In this embodiment,first coupler 100′ may be placed in a distal end of first conduit 190and may include a saddle 101, a channel 102, and a tissue clamp 103 ofdifferent configuration than those disclosed in previously-describedembodiments of the invention. For example, saddle 101′ and channel 102′of first coupler 100′ may have a substantially circular cross-sectionalthroughout their respective lengths, and tissue clamp 103 may have asubstantially circular cross-sectional that conforms to the shape ofsaddle 101′. Tissue clamp 103′ may include dimpled holes 105, teeth 109,or both, to improve the connection between tissue clamp 103′ and firstconduit 100 and to secure first conduit 100 between saddle 101′ andtissue clamp 103′. A second coupler 100 may be positioned in and securedto second conduit 109. First coupler 100′ and second coupler 100 may besecured together to form a conduit coupling device that establishesfluid communication between first conduit 190 and second conduit 191, sothat fluid may flow therebetween and bypass blockage 195, as illustratedby arrows in FIG. 26B.

[0130] In a further embodiment of the invention, couplers may beconfigured to form multiple conduit coupling devices and multipleconnections between conduits, as shown in FIG. 26C. In this embodiment,a single conduit 190 may be used to supply fluid to two or more blockedconduits 191, 192. The conduit 190 may be positioned transverse to eachblocked conduit 191, 192. A pair of couplers 100 may be used to form aconduit coupling device that establishes a connection between singleconduit 190 and each respective blocked conduit 191, 192. A coupler 100of each conduit coupling device is shown in broken lines in FIG. 26C.Because single conduit 190 may be positioned transversely to eachblocked conduit 191, 192, conduit coupling devices according to thisembodiment of the invention is adopted to conform to and maintainvarying angles 120, 121 between single conduit 190 and each blockedconduit 191, 192. Each coupler 100 may be rotated relative to the othercoupler of a pair of couplers that form a conduit coupling device toensure that each saddle 101 of a respective coupler is oriented within arespective conduit 191, 192 to reduce or eliminate tension betweensingle conduit 190 and blocked conduits 191, 192. The circularcross-section of each channel 102 adjacent to flange 106 of each coupler100 permits rotation of one coupler 100 relative to the other coupler100 without disrupting the flow path between couplers 100 of a conduitcoupling device. By connecting single conduit 190 to each blockedconduit 191, 192, fluid flow may be restored to each blocked conduit191, 192 at locations distal to blockages 195 in each blocked conduit191, 192.

[0131] In a still further embodiment of the invention, couplers 100 maybe configured to form a pair of conduit coupling devices, as shown inFIG. 26D, so that an adjacent conduit 190 may be used to bypass ablocked conduit 191. A first coupler 100 of each conduit coupling devicemay be positioned in blocked conduit 191 proximal to, and on either sideof, obstruction 195 in conduit 191. A second coupler 100 of each conduitcoupling device may be positioned in adjacent conduit 190. Firstcouplers 100 may be connected to respective second couplers 100 to formconduit coupling devices that allow fluid to flow through adjacentconduit 190 and bypass obstruction 195. Conduit 190 may be clipped atpositions 122, 123, so that adjacent conduit 190 may serve as a shortconduit for fluid to bypass obstruction 195. In this embodiment of theinvention, adjacent conduit 190 may comprise a vein, while blockedconduit 191 may comprise an artery.

[0132] In FIG. 30, an embodiment of holder and delivery device 160, asdiscussed above, is depicted. Device 160 is used to hold coupler 100 ofFIGS. 17-20 with tissue clamp 103 pulled up, e.g., away from, flange 106and mating surfaces 107, 107′, while coupler 100 is being placed intothe blood vessel. In this manner, device 160 prevents tissue clamp 103from interfering with the placement of coupler 100. Device 160 comprisesa handle 161 for grasping device 160 and a rotation knob 162 connectinga holding tube 163 having a flared end 165 to handle 161, wherebycoupler 100 may be rotated into position for placement in a bloodvessel. Thus, in accordance with FIGS. 31A and 31B, when rotation knob162 is rotated in the direction of arrow D, coupler 100 and flared end165 rotate in the direction of arrow E. An inner shaft 164 passesthrough tube 163 and is separate from and may move independently fromtube 163.

[0133]FIG. 32 depicts flared end 165 of device 160 of FIG. 31. Shaft 164ends in a conforming end 167, which is adapted to be received in channel102 of coupler 100. The distal end of tube 163 has opposing, clampreceiving flanges 166 a and 166 b. When in use, coupler 100 is insertedinto flared end 165 of device 160. Tissue clamp 103 is bent and held upand out of the way of saddle 101 of coupler 100 and the distal surfaceof device 160 by engagement with flanges 166 a and 166 b of device 160.Referring to FIG. 33, coupler 100 thus is held in position prior todelivery to a blood vessel by device 160 of FIG. 31.

[0134]FIG. 34 depicts coupler 100 immediately after its release fromdevice 160 of FIG. 31 for placement into position in a blood vessel (notshown). Once coupler 100 is placed into the designated blood vessel,flared end 165 is pulled back in the direction of arrow F, as shown inFIG. 34. As flared end 165 is drawn away from coupler 100, opposing,clamp receiving flanges 166 a and 166 b also are drawn away from coupler100. As opposing, clamp receiving flanges 166 a and 166 b are drawn awayfrom coupler 100, tissue clamps 103 slip from the grasp of flanges 166 aand 166 b and may snap onto the outer surface of the designated bloodvessel (not shown). Thus, tissue clamps 103, e.g., tissue clamps 103made from nitinol, may resume their pre-bent form and cover the sutureattachment of saddle 101 of coupler 100 to the designated blood vessel.

[0135] A further advantage of this design is that the heart is oftencooled below room temperature during surgery to limit tissue damageduring low or no flow conditions. If the tissue is cool, it then may bedifficult to warm the tissue clamp to cause it to change shape.

[0136] First coupler 100 may be applied to a vessel, as shown in thesequence of images depicted in FIGS. 35A-35D. In FIG. 35A, the surgeonmakes an incision into the vessel with scissors 90. In FIGS. 35B and35C, saddle 101 of first coupler 100 is positioned at the incision andthen pushed into the vessel using holder and delivery device 160. Asdescribed above with respect to FIG. 34, first coupler 100 is releasedfrom flared end 165 of holder and delivery device 160 is drawn back fromfirst coupler 100. Finally, as shown in FIG. 35D, after its release fromflared end 165 of holder and delivery device 160, tissue clamp 103clamps onto the vessel and seals first coupler 100 into the incision.Thus, this seal may be achieved without suturing.

[0137] In the sequence of FIGS. 35A-35D, first coupler 100 has beeninserted into a coronary vessel 1042. Following the insertion of firstcoupler 100 into coronary vessel 1042, a second or mating coupler 100may be inserted into branch vessel 1045 of IMA 1040, as shown in thesequence of FIGS. 36A and 36B. The order of placement of first andsecond couplers 100 is left to the judgment of the surgeon, for example,it might be desirable to the order described above and to place firstcoupler 100 into branch vessel 1045 of IMA 1040, followed by placementof second coupler 100 into coronary vessel 1042.

[0138] Referring to FIG. 37, a coupler connection device 300 is shownwhich may be used to join two coupler 100 together and thereby to coupletwo vessels. Coupler connection device 300 comprises a connection shaft301, a pair of coupler connecting arms 303 a and 303 b, and a connectingpivot 302 by which coupler connecting arms 303 a and 303 b are broughttogether. Coupler connection device 300 is guided into the patient'schest cavity by means of connection shaft 300 and mechanical,electrical, or electromagnetic signals, or the like, may be transmittedthrough connection shaft 300 to actuate one, either, or both of couplerconnecting arms 303 a and 303 b to connect couplers 100. Morespecifically, each of coupler connecting arms 303 a and 303 b may bepivotably attached to connecting pivot 302, and arched fingers 304 a and304 b may be formed at the distal end of each of coupler connecting arms303 a and 303 b. Arched fingers 304 a and 304 b are shaped to graspcouplers 100. Moreover, mechanical, electrical, or electromagneticsignals, or the like, may be transmitted through connection shaft 300and through coupler connecting arms 303 a and 303 b to actuate archedfingers 304 a and 304 b to grasp or release couplers 100. Thus, forexample, once arched fingers 304 a and 304 b on each coupler connectingarms 303 a and 303 b have grasped first and second couplers 100,respectively, coupler connecting arm 303 a may be held stationary andcoupler connecting arm 303 b may be actuated to swing in the directionof arrow G to connect first coupler 100 with second coupler 100.

[0139]FIG. 38 depicts a sequence of steps for using coupler connectiondevice 300 to connect two vessels, such as those described with respectto FIGS. 35A-35D, 36A, and 36B, with first and second couplers 100. InFIG. 38A, coupler connection device 300 has been inserted in to thepatient's chest cavity and arched fingers 304 a and 304 b on couplerconnecting arm 303 a have grasped first coupler 100 in coronary vessel1042 and arched fingers 304 a and 304 b on coupler connoting arm 303 bhave grasped second coupler 100 in branch vessel 1045 of IMA 1040.Referring to FIG. 38B, once coupler connecting arms 303 a and 303 b havegrasped first and second couplers 100, respectively, coupler connectingarm 303 a may be held stationary and coupler connecting arm 303 b may beactuated to swing toward coupler connecting arm 303 a to connect firstcoupler 100 with second coupler 100. Finally in FIG. 38C, first andsecond couplers 100 are joined together. Arched fingers 304 a and 304 bon each of coupler connecting arms 303 a and 303 b then may be actuatedto release first and second couplers 100, so that coupler connectiondevice 300 may be removed form the patient's chest cavity.

[0140]FIG. 39A depicts an external view of the final connected vessels,e.g., coronary vessel 1042 and branch vessel 1045 of IMA 1040, and FIG.39B depicts a cross-sectional view of the final connected vessels.Couplers 100 have been secured with clamping ring 108 and have createdand alternate flow path for blood around a damaged section of the vesselwithout the necessity of suturing the connections in place. FIG. 40depicts the placement of couplers 100 with respect to fulcrum device 14and incision 1020 in the patient's chest.

[0141] Exit

[0142]FIG. 41 shows the final result on the patient. The incision isclosed and leaves a small wound 1020′ on the patient.

[0143] While the invention has been described in connection withpreferred embodiments, it will be understood by those of ordinary skillin the art that other variations and modifications of the preferredembodiments described above may be made without departing from the scopeof the invention. Moreover, other embodiments of the present inventionwill be apparent to those of ordinary skill in the art from aconsideration of the specification or a practice of the inventiondisclosed herein, or both.

We claim:
 1. A coupler comprising: a saddle; a channel, wherein saidchannel comprises a first end having a substantially ellipticalcross-section connected to said saddle and a second end having asubstantially circular cross-section; a tissue clamp positioned aroundsaid channel; and a flange formed adjacent to said second end of saidchannel.
 2. The coupler of claim 1, wherein said tissue clamp comprisesa shape-memory alloy.
 3. The coupler of claim 2, wherein saidshape-memory alloy comprises a nickel titanium alloy.
 4. The coupler ofclaim 1, wherein said tissue clamp comprises a plurality of teethpositioned along a periphery of said tissue clamp.
 5. The coupler ofclaim 1, wherein said tissue clamp comprises a plurality of dimpledholes formed therethrough.
 6. The coupler of claim 1, wherein across-sectional area of said channel remains substantially constant assaid channel transitions from said first end to said second end.
 7. Thecoupler of claim 1, wherein a cross-sectional area of said channelincreases or decreases as said channel transitions from said first endto said second end.
 8. The coupler of claim 1, further comprising amating surface formed adjacent to said flange.
 9. The coupler of claim1, wherein said tissue clamp comprises a pair of legs, which extend andposition said tissue clamp adjacent to said saddle when said tissueclamp is heated to a transition temperature.
 10. The coupler of claim 1,wherein said tissue clamp is made from a material having an austenitictransition temperature less than about 10° C.
 11. The coupler of claim1, wherein said tissue clamp is made from a material having anaustenitic transition temperature about equal to or slightly greaterthan body temperature.
 12. The coupler of claim 10, wherein saidmaterial is nitinol.
 13. A method of connecting two conduits comprisingthe steps of: positioning a first saddle of a first coupler within afirst conduit; positioning a second saddle of a second coupler within asecond conduit; clamping said first conduit to said first saddle of saidfirst coupler; clamping said second conduit to said second saddle ofsaid second coupler; and connecting said first coupler and said secondcoupler.
 14. The method of claim 13, further comprising the step ofmaking an incision in said first conduit and positioning said saddle ofsaid first coupler within said first conduit.
 15. The method of claim13, further comprising the step of making an incision in said secondconduit and positioning said saddle of said second coupler within saidsecond conduit.
 16. The method of claim 13, wherein the step of clampingsaid first conduit to said first saddle comprises the step of heating afirst tissue clamp to a transition temperature, such that said firsttissue clamp secures said first conduit between said first tissue clampand said first saddle.
 17. The method of claim 13, wherein the step ofclamping said second conduit to said second saddle comprises the step ofheating a second tissue clamp to a transition temperature, such thatsaid second tissue clamp secures said second conduit between said secondtissue clamp and said second saddle.
 18. The method of claim 13, whereinthe step of clamping said first conduit to said first saddle comprisesthe step of extending a pair of legs formed in said first tissue clamp,such that said first tissue clamp secures said first conduit betweensaid first tissue clamp and said first saddle.
 19. The method of claim13, wherein the step of clamping said second conduit to said secondsaddle comprises the step of extending a pair of legs formed in saidsecond tissue clamp, such that said second tissue clamp secures saidsecond conduit between said second tissue clamp and said second saddle.20. The method of claim 13, wherein the step of connecting said firstcoupler and said second coupler comprises the steps of: positioning afirst flange of said first coupler in alignment with a second flange ofsaid second coupler; and crimping a clamping ring around said firstflange and said second flange to secure said first coupler and saidsecond coupler together.
 21. The method of claim 20, wherein the step ofpositioning a first flange of said first coupler in alignment with asecond flange of said second coupler comprises the step of engaging afirst mating surface of said first coupler and a second mating surfaceof said second coupler.
 22. The method of claim 13, wherein the step ofconnecting said first coupler and said second coupler precedes the stepsof positioning said first saddle and said second saddle in said firstconduit and said second conduit, respectively.
 23. A conduit couplingdevice comprising: a first coupler comprising a first saddle, a firstchannel, a first tissue clamp, and a first flange; a second couplercomprising a second saddle, a second channel, a second tissue clamp, anda second flange; a clamping ring for securing said first flange and saidsecond flange together.
 24. The conduit coupling device of claim 23,wherein said first channel and said second channel have substantiallyconstant cross-sectional area.
 25. The conduit coupling device of claim23, wherein said first channel and said second channel have varyingcross-sectional areas.
 26. The conduit coupling device of claim 23,further comprising a first mating surface formed adjacent to said firstflange and a second mating surface formed adjacent to said secondflange.
 27. The conduit coupling device of claim 23, wherein said firsttissue clamp and said second tissue clamp comprise a shape-memory alloy.28. The conduit coupling device of claim 23, wherein each of said firsttissue clamp and said second tissue clamp comprise a plurality ofdimpled holes formed therethrough.
 29. The conduit coupling device ofclaim 23, wherein said first tissue clamp and said second tissue clampcomprise a plurality of teeth positioned along a periphery of said firsttissue clamp and said second tissue clamp.
 30. The conduit couplingdevice of claim 23, wherein said first channel comprises a first end ofsubstantially elliptical cross-section connected to said first saddleand a second end of substantially circular cross-section adjacent tosaid first flange.
 31. The conduit coupling device of claim 23, whereinsaid second channel comprises a first end of substantially ellipticalcross-section connected to said second saddle and a second end ofsubstantially circular cross-section adjacent to said second flange. 32.The conduit coupling device of claim 23, wherein said first coupler maybe positioned at varying positions relative to said second coupler, sothat said first saddle and said second saddle may be positioned atvarying positions relative to one another.
 33. The conduit couplingdevice of claim 23, wherein said first channel comprises a first end ofsubstantially circular cross-section connected to said first saddle anda second end of substantially circular cross-section adjacent to saidfirst flange.
 34. A coupler holder and delivery device for holding anddelivering a coupler into a blood vessel, said coupler comprising asaddle; a channel, wherein said channel comprises a first end connectedto said saddle and a second end; a tissue clamp positioned around saidchannel; and a flange formed adjacent to said second end of saidchannel, said coupler holder and delivery device comprising: an outertube surrounding an inner shaft, such that said outer tube is slidableon said inner shaft and independently of said inner shaft; a couplerconforming end, which is mounted on a first end of said inner shaft andis adapted to engage said second end of said channel of said coupler;and a pair of opposing, tissue clamp receiving flanges mounted onopposite sides of a first end of said outer tube and adapted to engagesaid tissue clamp bend said tissue clamp away from said saddle, whereinsaid outer tube is slidable toward said first end of said inner shaft toengage said flanges to said tissue clamp, and wherein said outer tube isslidable away from said first end of said inner shaft to release saidtissue clamp from said flanges.
 35. A method for delivering a couplerinto a blood vessel, said coupler comprising a saddle; a channel,wherein said channel comprises a first end connected to said saddle anda second end; a tissue clamp positioned around said channel; and aflange formed adjacent to said second end of said channel, said methodcomprising the steps of: engaging said channel of said coupler; engagingsaid tissue clamp and bending said tissue clamp away from said saddle;making an incision into said blood vessel; delivering said coupler intosaid blood vessel through said incision; securing said saddle to saidblood vessel; and releasing said tissue clamp, so that said tissue clampconforms to said saddle.
 36. A system for performing vascular surgery,comprising: a first retractor blade and a second retractor blade,wherein said first retractor blade comprises a first grasping bar andsaid second retractor blade comprises a second grasping bar and whereinsaid first retractor blade and said second retractor blade are adaptedto engage opposing edges of an incision in a patient; a fulcrum devicecomprising a first fulcrum slot and a second fulcrum slot formed throughopposing edges of said fulcrum device, wherein said first fulcrum slotis adapted to receive said first grasping bar and said second fulcrumslot is adapted to receive said second grasping bar, such that saidfulcrum device is adapted to apply leverage from said first retractorblade and said second retractor blade to spread the edges of theincision and to allow access to a chest cavity of the patient.
 37. Thesystem of claim 36, further comprising a first bar and a first mountingbracket and a second bar and a second mounting bracket, wherein saidfirst retractor blade is mounted adjustably and pivotably on said firstbar by said first mounting bracket and said second retractor blade ismounted adjustably and pivotably on said second bar by said secondmounting bracket, whereby a separation between the first retractor bladeand said second retractor blade is adjustable to increase or decreasethe separation between the edges of the incision in the patient.
 38. Thesystem of claim 36, further comprising a surgical table comprising acentral support for supporting the patient's head and trunk, a pair ofarm supports extending from opposing edges of said central support, anda pair of leg supports for supporting and separating the patient's legs,whereby an angle of separation between the patient's legs is adjustableto permit improved access to the patient's chest by a surgeon standingbetween the patient's legs.
 39. The system of claim 38, furthercomprising a first bar and a first mounting bracket and a second bar anda second mounting bracket, wherein said first retractor blade is mountedadjustably and pivotably on said first bar by said first mountingbracket and said second retractor blade is mounted adjustably andpivotably on said second bar by said second mounting bracket and whereinsaid first bar and said second bar are mounted on said surgical table,whereby a separation between the first retractor blade and said secondretractor blade is adjustable.
 40. The system of claim 36, wherein saidfulcrum device further comprises a perimeter lip having an (window-like)access opening formed therewithin, a pair of parallel first rails whichextend across said access opening, and an instrument support slidablymounted between said pair of parallel first rails, such that saidinstrument support holds a surgical instrument inserted into thepatient's chest cavity.
 41. The system of claim 40, wherein saidinstrument support further comprises a pair of first grasping runners,which slidably engage said pair of parallel first rails; a pair ofparallel second rails which extend between said pair of first graspingrunners; and an instrument port slidably mounted between said pair ofparallel second rails, whereby said instrument port is positionablewithin said access opening along a first axis parallel to said pair ofparallel first rails and along a second axis parallel to said pair ofparallel second rails and perpendicular to said first axis.
 42. Thesystem of claim 41, wherein said instrument port further comprises apair of second grasping runners which slidably engage said pair ofparallel second rails and an instrument access orifice formedtherethrough, such that said instrument access orifice receives asurgical instrument and holds it at a position within said accessopening.
 43. The system of claim 36, wherein said fulcrum device furthercomprises a light source to illuminate the chest cavity.
 44. The systemof claim 43, wherein said light source comprises a plurality of lightemitting diodes arrayed about a side of said perimeter lip facing thepatient's chest cavity.
 45. The system of claim 43, wherein said lightsource comprises at least one fiber optic cable to convey light to aplurality of fiber optic cable ends arrayed about a side of saidperimeter lip facing the patient's chest cavity.
 46. The system of claim36, wherein said fulcrum device further comprises at least one fulcrumpassage and wherein a heart blade, wherein said at least one fulcrumpassage is adapted to receive said heart blade therethrough, wherebysaid heart blade positions the patient's heart during surgery.
 47. Thesystem of claim 38, wherein said surgical table further comprises avideo monitor and a camera, whereby images of the patient's chest cavityare displayed on said video monitor.
 48. The system of claim 36, furthercomprising an endoscope and an endoscope holding device, wherein saidendoscope holding device comprises a first ball joint, a second balljoint, and a manipulating shaft extending between said first ball jointand said second ball joint; an endoscope stabilizing device supportingsaid second ball joint, whereby said endoscope holding device is fixedto a stationary object; a handle mounted on said first ball jointcomprising a passage formed therethrough for receiving said endoscopeand a activating lever, whereby said first ball joint and said secondball joint are released and secured.
 49. The system of claim 48, furthercomprising a first bar and a first mounting bracket and a second bar anda second mounting bracket, wherein said stationary object is selectedfrom the group consisting of said first bar and said second bar andwherein said first retractor blade is mounted adjustably and pivotablyon said first bar by said first mounting bracket and said secondretractor blade is mounted adjustably and pivotably on said second barby said second mounting bracket, whereby a separation between the firstretractor blade and said second retractor blade is adjustable.
 50. Thesystem of claim 48, wherein said endoscope further comprises a camera.51. The system of claim 36, further comprising a dissecting instrumentfor separating tissue, said dissecting instrument comprising a handle, ashaft, and a tip, wherein said shaft is rotatable and said tip isrotatable and pivotable on said shaft and wherein said tip comprisesdissecting means.
 52. The system of claim 51, wherein said dissectingmeans comprises a spatula end affixed to a spatula end shaft and agrasper jaw affixed to said spatula end shaft, such that said grasperjaw is brought into contact with said spatula end to blunt dissecttissue positioned therebetween.
 53. The system of claim 50, wherein afirst button mounted on said handle is manipulated to pivot said tip viamechanical couplings within said shaft.
 54. The system of claim 52,wherein a second button mounted on said handle is manipulated to actuatesaid grasper jaw via mechanical couplings within said shaft.
 55. Thesystem of claim 51, wherein said dissecting means comprises a source ofCO₂ and a gas flow passage for conveying CO₂ to said tip, whereby a flowof CO₂ separates impacted tissue into natural tissue planes prior todissection.
 56. The system of claim 51, wherein said dissecting meanscomprises a source of RF energy and a conduit for conveying RF energy toan innermost surface of spatula end shaft.
 57. The system of claim 56,wherein a second button mounted on said handle is manipulated to actuatesaid grasper jaw via mechanical couplings within said shaft to seizetissue to coagulate blood in said tissue prior to dissection.
 58. Thesystem of claim 51, wherein said dissecting means comprises a spatulaend affixed to a spatula end shaft and a grasper jaw affixed to saidspatula end shaft, such that said grasper jaw is brought into contactwith said spatula end to blunt dissect tissue positioned therebetween; asource of CO₂ and a gas flow passage for conveying CO₂ to said tip,whereby a flow of CO₂ separates impacted tissue into natural tissueplanes prior to dissection; and a source of RF energy and a conduit forconveying RF energy to an innermost surface of spatula end shaft. 59.The system of claim 36, further comprising a cannula comprising astabilizer and manipulation component and a catheter component.
 60. Thesystem of claim 59, wherein said stabilizer and manipulation componentis adapted to receive said catheter component and comprises a suctioncup adapted to secure said stabilizer and manipulation component to anapex of the patient's heart; a suction tube through which fluid is drawnto create suction between said suction cup and the heart; a stabilizershaft which passes through said suction cup and is adapted to penetratethe heart through an incision; a hemostatic valve in communication withsaid stabilizer shaft for insertion of said catheter component into theheart; and a manipulator arm and handle for guiding said suction cupinto contact with the heart.
 61. The system of claim 59, wherein saidcatheter component is adapted to be received by said stabilizer andmanipulation component and comprises at least one catheter tube adaptedto pass through said stabilizer and manipulation component in to thepatient's heart; a proximal balloon, which deploys radially in the leftventricle; a distal balloon that deploys radially in the ascendingaorta, at least one radial discharge opening formed in said at least onecatheter tube between said distal balloon and said proximal balloon; anda distal discharge opening formed at the tip of said at least onecatheter tube.
 62. The system of claim 60, wherein said cathetercomponent is adapted to be received by said stabilizer and manipulationcomponent and comprises at least one catheter tube adapted to passthrough said stabilizer and manipulation component in to the patient'sheart; a proximal balloon, which deploys radially in the left ventricle;a distal balloon that deploys radially in the ascending aorta, at leastone radial discharge opening formed in said at least one catheter tubebetween said distal balloon and said proximal balloon; and a distaldischarge opening formed at the tip of said at least one catheter tube.63. The system of claim 36, further comprising tissue scissorscomprising a scissors handle, a scissors shaft, a distal end pivotableon said scissors shaft at a distal end joint; a slidable button mountedon said scissors handle and operably connected to said distal end joint,whereby said distal end is pivoted; a pair of scissor blades mounted onsaid distal end; and a handle ring operably connected to at least one ofsaid pair of scissor blades, whereby at least one of said pair ofscissor blades in urged into contact with the other of said pair ofscissor blades.
 64. The system of claim 63, wherein said tissue scissorsfurther comprises a source of RF energy and a conduit for conveying RFenergy to at least one of said pair of scissor blades.
 65. The system ofclaim 36, further comprising a coupler connection device for connectinga pair of couplers to each other, comprising a connection shaft, a pairof coupler connecting arms, and a connecting pivot; wherein each of saidcoupler connecting arms further comprises a pair of arched fingerspositioned at the end of said coupler connecting arm opposite saidconnecting pivot, which grasp one of said pair of couplers, and whereinat least one of said pair of coupler connecting arms pivots on saidconnecting pivot towards the other of said pair of coupler connectingarms to connect said couplers to each other.
 66. A method of performingvascular surgery, comprising the steps of: making a subcostal incisionin a patient; engaging opposing edges of said incision with a firstretractor blade and a second retractor blade; mounting a fulcrum deviceon said first retractor blade and said second retractor blade;retracting said incision to provide access to the patient's chest cavitythrough which to operate; placing a heart blade through said fulcrumdevice; inserting an endoscope through said fulcrum device to locatedamage in a coronary vessel; positioning the heart with said heart bladeto expose said damaged coronary vessel and a branch of the InternalMammary Artery (IMA); inserting a cannula through said fulcrum deviceinto the apex of the patient's heart to place the patient oncardiopulmonary bypass; making a vessel incision in said coronary vesseldownstream from said located damage in said coronary vessel andinserting a first conduit coupler into said vessel incision; making anIMA incision in said IMA and inserting a second conduit coupler intosaid IMA incision; connecting said first conduit coupler to said secondconduit coupler; removing said cannula from the patients heart; andsupplying blood to tissue downstream of said located damage via saidfirst conduit coupler and said second conduit coupler.